Health Service Focus

15.08.19

Improving commercial contract research in the NHS

Source: NHE Jul/Aug 19

Clare Morgan, research delivery director at the National Institute for Health Research’s (NIHR) Clinical Research Network (CRN), looks at why the rollout of a single contract review for commercial contract research is good news for all.

Growth in the volume of commercial contract research has been strong over the last few years; in 2018-19, the NIHR CRN supported 1,523 commercial studies open to recruitment in the NHS, compared to just 415 in 2010-11. The NHS offers a vibrant research environment, yet more needs to be done to facilitate the delivery of research and innovation. 

Dr Sam Roberts, director of life sciences at NHS England (NHSE) and NHS Improvement (NHSI) and chief executive of the Accelerated Access Collaborative (AAC), said: “We’ve seen enormous development across the whole of research and development in the last few years. In 2017, in partnership with the NIHR, we published ‘Twelve Actions to Support and Apply Research in the NHS.’ 

“Since then, we have placed an obligation through the NHS Standard Contract for NHS providers in England to use new, streamlined processes. We are continuing to simplify and standardise those processes under a single contract review process, to support mandated use of unmodified model site agreements and standard costing methodology. 

“Coupled with the newly-strengthened Accelerated Access Collaborative, we are on the brink of another big increase in England’s research and innovation activity. It’s a really exciting time for us all.” 

This single contract review process for commercial contract research aims to provide a consistent nationwide approach to resource allocation, negotiations and final agreed site costs. The implementation phase sees a designated volunteer national coordinator in an NHS R&D team reviewing the costing template, completed by industry, to ensure study resource and procedures are robustly allocated using costing template methodology. 

This will support a ‘review once and share’ approach for all participating sites. It also allows for greater commercial research costing transparency, and formally endorses NHS provider staff to act in a nationwide capacity with defined accountability linked to the NHS provider standard contract. 

Rollout of the single contract review process is underpinned by the new interactive Costing Tool (iCT) managed by the NIHR CRN - an improved, online version of the Industry Costing Template introduced more than ten years ago. iCT supports the workflow for the costing process and provides greater transparency of costing negotiations and agreed costs at participating sites, making it quicker and easier to set up NHS commercial studies. 

Implementation of the single contract review process is now underway using a phased approach, and the National Directive for Commercial Contract Research Studies will be reviewed and revised throughout 2019. Phase one has involved volunteer national coordinators from participating sites conducting an enhanced validation on a single study to better understand variation in site costs and training requirements for national coordinators. 

The second phase commenced this July, with a small number of commercial studies closely supported to progress through the process. The third phase will involve the assessment of the new process delivered at scale for all new studies, ensuring that the approach is sustainable and provides a high-quality service which speeds up costing negotiations and consistency for multi-centre studies. It is anticipated that the final phase, entering business as usual activity, will begin in early 2020. 

An initial plan was developed by partners in 2018, involving industry and the R&D community. Following this, NHSE and NHSI asked the most active commercial contract research organisations to test and shape the new process, nominating volunteer national coordinators with extensive commercial costing experience. 

Implementation is overseen by an advisory group which draws together representation from a number of industries and NHS and R&D organisations and regulators, ensuring that stakeholder feedback is considered throughout implementation. Ongoing stakeholder focus groups are also being held to seek and act on arising feedback and learnings.

By simplifying and improving arrangements to set up and deliver research, we can support patients to receive the best care by speeding up access to new treatments. This will build on the excellent reputation of the NHS and will attract more global clinical research from commercial companies, which serves to benefit patients, NHS providers and the wider UK economy.

For more information

Tw: @NIHRresearch

W: tinyurl.com/nhenihrcrn

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